ࡱ > 8 bjbj 0 u u 1 ) ) ) ) ) ) ) ) 8 ,* < h+ < ) З , 1 ( 1 1 1 3 ` 5 5 T Ö Ŗ Ŗ Ŗ Ŗ Ŗ Ŗ $ N ] ) 6 3 3 6 6 ) ) 1 1 F B = = = 6 H ) 1 ) 1 Ö = 6 Ö = = 1 mn ) 7 ; ` H З L 7 ) 6 6 = )6 56 \ 6 6 6 9 . 6 6 6 З 6 6 6 6 6 6 6 6 6 6 6 6 6 ( : R e q u e s t o f s c i e n t i f i c a d v i c e A p p l i c a t i o n f o r m N a m e o f t h e c o m p a n y F O R M T E X T S m a l l a n d m e d i u m s i z e d e n t e r p r i s e s ( S M E ) s t a t u s F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o C o n t a c t p e r s o n d e t a i l s T i t l e a n d n a m e : F O R M T E X T T e l : F O R M T E X T e - m a i l : F O R M T E X T N a m e o f t h e p r o d u c t F O R M T E X T N a m e o f t h e a c t i v e s u b s t a n c e F O R M T E X T A T C c o d e F O R M T E X T T h e r a p e u t i c f i e l d F O R M C H E C K B O X C a n c e r F O R M C H E C K B O X H I V / A I D S F O R M C H E C K B O X D i a b e t e s F O R M C H E C K B O X N e u r o d e g e n e r a t i v e d i s o r d e r F O R M C H E C K B O X V i r a l d i s e a s e F O R M C H E C K B O X A u t o i m m u n e d i s e a s e / d y s f u n c t i o n F O R M C H E C K B O X O t h e r ( p l e a s e s p e c i f y ) I n t e n d e d i n d i c a t i o n ( s ) f o r t h e s c o p e o f t h e c u r r e n t S A F O R M T E X T T y p e o f product FORMCHECKBOX Chemicals: FORMCHECKBOX Generic FORMCHECKBOX Antisense FORMCHECKBOX NCE FORMCHECKBOX Others FORMCHECKBOX Herbals FORMCHECKBOX Bio(techno)logical FORMCHECKBOX Classical biological: FORMCHECKBOX Blood derived FORMCHECKBOX Vaccine FORMCHECKBOX Enzyme FORMCHECKBOX Other biologicals FORMCHECKBOX Recombinant DNA derived product: FORMCHECKBOX Cytokine FORMCHECKBOX Hormone FORMCHECKBOX Monoclonal antibody FORMCHECKBOX Vaccine FORMCHECKBOX Transgene-derived FORMCHECKBOX Other FORMCHECKBOX Similar biological FORMCHECKBOX Nucleic acid-based: FORMCHECKBOX DNA vaccine FORMCHECKBOX Oncolytic virus FORMCHECKBOX Advanced therapy: FORMCHECKBOX Gene Therapy : FORMCHECKBOX Autologous FORMCHECKBOX Allogeneic FORMCHECKBOX Xenogeneic FORMCHECKBOX Somatic cell therapy: FORMCHECKBOX Autologous FORMCHECKBOX Allogeneic FORMCHECKBOX Xenogeneic FORMCHECKBOX Tissue-engineered product: FORMCHECKBOX Autologous FORMCHECKBOX Allogeneic FORMCHECKBOX Xenogeneic FORMCHECKBOX Therapeutic, scientific or technical innovation Comments:Type of request FORMCHECKBOX Initial request FORMCHECKBOX Follow-up to the initial request What is the state of development of the product at present? -Pharmaco-toxicological -Clinical Phase I II III -Dossier finalised -Approved: FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX (Intended) legal basis of the application FORMCHECKBOX Art. 8(3) Complete application FORMCHECKBOX Art.10.(1) Generic application FORMCHECKBOX Art.10.(3) Hybrid application FORMCHECKBOX Art.10.(4) Similar biological application FORMCHECKBOX Art.10.a Well-established use application FORMCHECKBOX Art.10.b Fixed combination application FORMCHECKBOX Art.10.a Informed consent application FORMCHECKBOX Art.16a Traditional use registration FORMCHECKBOX Variation to MA Orphan Status FORMCHECKBOX Yes FORMCHECKBOX NoHave you already chosen a registration procedure or which procedure has been followed?National Procedure Mutual Recognition Decentralised procedure Centralised p r o c e d u r e T o b e d e c i d e d F O R M C H E C K B O X [ A I C n u m b e r ] F O R M C H E C K B O X [ M R P n u m b e r ] F O R M C H E C K B O X [ D C P n u m b e r ] F O R M C H E C K B O X F O R M C H E C K B O X W h a t i s t h e i n t e n d e d f i l i n g d a t e ( i f a p p l i c a b l e ) ? F O R M T E X T [ d d - m m - y y y y ] A r e a o f a d v i c e FORMCHECKBOX Quality FORMCHECKBOX Preclinical FORMCHECKBOX Clinical FORMCHECKBOX Pharmacokinetics FORMCHECKBOX Statistics FORMCHECKBOX Safety/Efficacy FORMCHECKBOX Risk management plans FORMCHECKBOX HTA FORMCHECKBOX Other, please specify: Please specify the justification for request (e.g. no guidance available, new area of development) FORMTEXT \ ^ ` 2 ļpWF1F )j h' hqX OJ QJ U^J mH sH h' hqX OJ QJ ^J mH sH 0j h' h OJ QJ U^J mH nH sH u /j h' h OJ QJ U^J mH sH )j h' h OJ QJ U^J mH sH h' h OJ QJ ^J mH sH h5Q OJ QJ ^J mH sH h mH sH hsF h :mH sH .h' h6 5:CJ OJ QJ ^J aJ mH sH .h' h 5:CJ OJ QJ ^J aJ mH sH : \ ^ ` B y kdt $$If F 4 @0 Q' 0 ' 4 F a f4ytP $If gdBJf $a$gd 2 $$d %d &d 'd -D M N O P Q a$gd @ j l L | y kd $$If F 4 @0 Q' 0 ' 4 F a f4ytP $If gdBJf 2 4 6 : > @ B ^ ` b f h l veT?T )j h' hI OJ QJ U^J mH sH h' hI OJ QJ ^J mH sH h' hU OJ QJ ^J mH sH h' h OJ QJ ^J mH sH h' h OJ QJ ^J mH sH /j h' hqX OJ QJ U^J mH sH h' h OJ QJ ^J mH sH h' hqX OJ QJ ^J mH sH )j h' hqX OJ QJ U^J mH sH /j- h' hqX OJ QJ U^J mH sH $ & : < > H J L N t v ҹҨ҆nҹҗ҆VҹҗH hI OJ QJ ^J mH sH /j h' hI OJ QJ U^J mH sH /j* h' hI OJ QJ U^J mH sH h' hI OJ QJ ^J mH sH h' hU OJ QJ ^J mH sH h' h OJ QJ ^J mH sH 0j h' hI OJ QJ U^J mH nH sH u )j h' hI OJ QJ U^J mH sH /j h' hI OJ QJ U^J mH sH L N v | | $If gdBJf y kd $$If F 4 @0 Q' 0 ' 4 F a f4ytP v x . 0 2 < > B ِ{jR{9{ 0j h' h6 OJ QJ U^J mH nH sH u /j% h' h6 OJ QJ U^J mH sH h' h6 OJ QJ ^J mH sH )j h' h6 OJ QJ U^J mH sH /j h' h OJ QJ U^J mH sH 0j h' h OJ QJ U^J mH nH sH u /j h' h OJ QJ U^J mH sH h' h OJ QJ ^J mH sH )j h' h OJ QJ U^J mH sH | | $If gdBJf y kd? $$If F 4 @0 Q' 0 ' 4 F a f4ytP @ | | $If gdBJf y kdl $$If F 4 @0 Q' 0 ' 4 F a f4ytP @ B h ` R | | | $If gdBJf y kd $$If F 4 @0 Q' 0 ' 4 F a f4ytP B h j $ & ( * ` ڰeM; #h hqX 5OJ QJ ^J mH sH /j h' hqX OJ QJ U^J mH sH 2j" h' hqX 5OJ QJ U^J mH sH 2j h' hqX 5OJ QJ U^J mH sH ,j h' hqX 5OJ QJ U^J mH sH #h' hqX 5OJ QJ ^J mH sH /jR h' hqX OJ QJ U^J mH sH )j h' hqX OJ QJ U^J mH sH h' hqX OJ QJ ^J mH sH ` b ~ " , N P R T ף}e}S?} &h' hqX hqX OJ QJ ^J mH sH #h' h,8 5OJ QJ ^J mH sH /j h' hqX OJ QJ U^J mH sH h' hqX OJ QJ ^J mH sH )j h' hqX OJ QJ U^J mH sH 2jZ h' hqX 5OJ QJ U^J mH sH 2j h' hqX 5OJ QJ U^J mH sH #h' hqX 5OJ QJ ^J mH sH ,j h' hqX 5OJ QJ U^J mH sH R T | | $If gdBJf y kd* $$If F 4 @0 Q' 0 ' 4 F a f4ytP T f ޱɘއvYD )j h' h OJ QJ U^J mH sH 9h' h 56CJ OJ QJ ]^J aJ mH nHsH tH h' h OJ QJ ^J mH sH h' h OJ QJ ^J mH sH 0j h' h OJ QJ U^J mH nH sH u /j h' h OJ QJ U^J mH sH )j h' h OJ QJ U^J mH sH h' h OJ QJ ^J mH sH h' hU OJ QJ ^J mH sH ' | k Q Q 7 $7$ 8$ H$ If ]^gdZ $7$ 8$ H$ If ]^gdqX $If ]^gd6 $If gdBJf y kdW $$If F 4 @0 Q' 0 ' 4 F a f4ytP & ' 1 2 @ A B C N O ] |dR6 6h' h 5CJ OJ QJ ]^J aJ mH nHsH tH #h' h 5OJ QJ ^J mH sH /jx h' h OJ QJ U^J mH sH 3h' h CJ OJ QJ ]^J aJ mH nHsH tH3h' h CJ OJ QJ ]^J aJ mH nHsH tH h' h OJ QJ ^J mH sH h' h OJ QJ ^J mH sH )j h' h OJ QJ U^J mH sH /j h' h OJ QJ U^J mH sH ] ^ _ h k l z { | ҶҥҶҥuҶdOd7Od /j h' h OJ QJ U^J mH sH )j h' h OJ QJ U^J mH sH h' h OJ QJ ^J mH sH /j h' h OJ QJ U^J mH sH /jH h' h OJ QJ U^J mH sH h' h OJ QJ ^J mH sH 6h' h 5CJ OJ QJ ]^J aJ mH nHsH tH )j h' h OJ QJ U^J mH sH /j h' h OJ QJ U^J mH sH ιeMe1 6h' h 5CJ OJ QJ ]^J aJ mH nHsH tH /j h' h OJ QJ U^J mH sH 3h' h CJ OJ QJ ]^J aJ mH nHsH tH h' h OJ QJ ^J mH sH /j h' h OJ QJ U^J mH sH h' h OJ QJ ^J mH sH )j h' h OJ QJ U^J mH sH -hZ CJ OJ QJ ]^J aJ mH nHsH tH3h' h CJ OJ QJ ]^J aJ mH nHsH tH T 4 % m $ R ? h a $7$ 8$ H$ If ]gd' $7$ 8$ H$ If ]gdqX $7$ 8$ H$ If ]^gdZ ' ( ) 8 9 G H I Q T ^ _ m n o p w ٍwffNf2 6h' h 5CJ OJ QJ ]^J aJ mHnHsHtH /j h' h OJ QJ U^J mH sH h' h OJ QJ ^J mHsH +h' h 5CJ OJ QJ ^J aJ mH sH /j h' h OJ QJ U^J mH sH 6h' h 5CJ OJ QJ ]^J aJ mH nHsH tH /jP h' h OJ QJ U^J mH sH h' h OJ QJ ^J mH sH )j h' h OJ QJ U^J mH sH w ˶qUqD3 h' h OJ QJ ^J mH sH h' h OJ QJ ^J mHsH 6h' h6 5CJ OJ QJ ]^J aJ mHnHsHtH 6h' h 5CJ OJ QJ ]^J aJ mHnHsHtH /j h' h OJ QJ U^J mH sH h' h OJ QJ ^J mHsH )j h' h OJ QJ U^J mH sH 0h' 5CJ OJ QJ ]^J aJ mHnHsHtH 6h' h= 5CJ OJ QJ ]^J aJ mHnHsHtH ) ҸҧeI0ҧ 0h' 5CJ OJ QJ ]^J aJ mH nHsH tH 6h' h= 5CJ OJ QJ ]^J aJ mH nHsH tH 6h' h 5CJ OJ QJ ]^J aJ mH nHsH tH /jX h' h OJ QJ U^J mH sH hZ OJ QJ ^J mH sH h' h OJ QJ ^J mH sH 3h' h CJ OJ QJ ]^J aJ mH nHsH tH)j h' h OJ QJ U^J mH sH /j h' h OJ QJ U^J mH sH ) * + > @ A O P Q d f g u v w ҶҌtҶҌ\Ҷ@Ҍ 6h' h= 5CJ OJ QJ ]^J aJ mH nHsH tH /j h' h OJ QJ U^J mH sH /j( h' h OJ QJ U^J mH sH h' h OJ QJ ^J mH sH 0h' 5CJ OJ QJ ]^J aJ mH nHsH tH 6h' h 5CJ OJ QJ ]^J aJ mH nHsH tH )j h' h OJ QJ U^J mH sH /j h' h OJ QJ U^J mH sH ҶpXҶ